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Specific requirements of detailed rules for drug packaging and labeling specifications

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I. chemicals and biological products and preparations:
(I) the contents of the inner packaging label include:
[drug name], [Specification], [indication], [usage and dosage], [storage], [production date], [production batch number], [validity period] and [manufacturer]. If the above contents cannot be marked completely due to the packaging size, they can be reduced appropriately, but at least three items (such as ampoule, eye drop bottle, injection bottle, etc.) must be marked
(II) the contents of the outer packaging labels that directly contact the inner packaging include:
[drug name], [ingredient], [Specification], [indication], [usage and dosage], [storage], [adverse reactions], [contraindications], [precautions], [packaging], [production date], [production batch number], [validity period], [approval number] and [manufacturer]. If adverse reactions, contraindications and precautions cannot be indicated due to the size of the package, the words “see the instructions for details” shall be indicated
for preventive biological products, the above [indications] should be listed as [vaccination object]
(III) the contents of large package labels include:
[drug name], [Specification], [production batch number], [production date], [validity period], [storage], [packaging], [approval number], [manufacturer], transportation precautions or other marks
II. The contents of API labels include:
[drug name], [packaging specification], [production batch number], [production date], [validity period], [storage], [approval number], [manufacturer], transportation precautions or other marks
III. traditional Chinese medicine preparations:
(I) the contents of the inner package label include:
[drug name], [Specification], [function and indications], [usage and dosage], [storage], [production date], [production batch number], [validity period] and [manufacturer]. If the above contents cannot be fully indicated due to the size limitation of the label, they can be appropriately reduced, but at least three items must be marked, such as [drug name], [Specification] and [production batch number], such as ampoules, injection bottles, etc. The wax shell of traditional Chinese medicine honey pill must at least be marked with [drug name]
(II) the contents of the label of the outer package in direct contact with the inner package include:
[drug name], [ingredient], [Specification], [function and indications], [usage and dosage], [storage], [adverse reactions], [contraindications], [precautions], [packaging], [production date], [production batch number], [validity period] [approval number] and [manufacturer]. If adverse reactions, contraindications and precautions cannot be indicated due to the size of the package, the words “see the instructions for details” shall be indicated
(III) the contents of large package labels include:
[drug name], [Specification], [production batch number], [production date], [validity period], [storage], [packaging], [approval number], [manufacturer], transportation precautions or other marks
these Rules shall come into force as of the date of promulgation
the detailed rules shall be interpreted by the State Drug Administration

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